Shire Pharmaceuticals receives good FDA feedback for ADHD treatment

Shire Pharmaceuticals has received an approvable letter from the US Food and Drug Administration (FDA) for its attention deficit hyperactivity disorder (ADHD) treatment Daytrana.

The letter contained proposed labelling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies for the transdermal patch Daytrana (methylphenidate transdermal system).

Shire has responded by announcing it will communicate with the FDA to address the issues.

Matthew Emmens, Shire CEO, said: “This approvable letter for Daytrana is positive news for Shire and our partner, Noven Pharmaceuticals.

“We look forward to working with the FDA to agree on the final labelling for Daytrana. As the first and only non-oral medication for ADHD, Daytrana, if ultimately approved, will be a welcome new alternative to current therapies for patients diagnosed with ADHD.”

The company expects to reach a final agreement with the FDA in the first half of this year.

Daytrana is licensed globally to Shire from Noven.

© Adfero Ltd